Compression apparatus for applying localized pressure to a limb

ABSTRACT

An apparatus is provided for applying compression therapy to an extremity of the human body, such as a portion of the human leg. The device includes a flexible member and an air bladder. The flexible member is adapted to wrap around the extremity to secure the air bladder chamber to the extremity. An air pumping mechanism is operated to inflate the air bladder chamber to a pressurized state. One or more fluid-filled pressurized members are provided, each separate and distinct from the flexible member and the air bladder chamber and thus readily moveable relative to the flexible member and the air bladder chamber. The pressurized member(s) preferably includes a sponge on its underside and is operably disposed between the extremity and the flexible member whereby it applies increased localized pressure to the extremity during use. The pressurized member(s) can be positioned during use such that it covers a venous ulcer (or other treatment sites) and applies increased localized pressure to the treatment site in order to promote healing.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 11/050,104, which is a continuation-in-part of U.S.patent application Ser. No. 10/400,901, both commonly assigned toassignee of the present invention, and both herein incorporated byreference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical apparatus. More particularly, thisinvention relates to mechanisms for applying pressure to a limb of thehuman body. While the invention has particular application inconjunction with the treatment of venous ulcers of the leg and possiblywith other forms of medical treatment (e.g., sclerotherapy or veinstripping/removal for treatment for varicose veins) of the leg or otherextremity, it is not limited thereto.

2. State of the Art

A venous ulcer is damage and loss of skin above the ankle that is theresult of a problem with the veins in the leg. Venous ulcers typicallydevelop on either side of the lower leg, above the ankle and below thecalf. They are difficult to heal and often recur.

The veins of the leg are divided into the superficial and deep systemsaccording to their position relative to the fascia.

The deep veins, which come together to form the popliteal and femoralveins lie within the fascia and are responsible for the venous returnfrom the leg muscles. Dilated valve less sinusoids also lie within thefascia (more particularly in the soleus and gastrocnemius muscles). Thesinusoids fill with blood when the leg is at rest.

The long saphenous vein which runs along the medial side of the leg fromfoot to groin and the short saphenous vein which runs at the back of thecalf from foot to knee are the major vessels of the superficial venoussystem. These vessels lie outside the fascia and are responsible for thevenous return from the skin and subcutaneous fat.

Communicating veins, sometimes called perforators because they perforatethe deep fascia, join the two systems. The perforators, like the otherveins in the leg, contain valves that permit the flow of blood in onedirection only, from the outer or superficial system inwards to the deepveins.

The venous pressure at the ankle of a subject who is lying supine isaround 10 mmHg, but on standing this will rise considerably due to anincrease in hydrostatic pressure (equivalent to the weight of a verticalcolumn of blood stretching from the point of measurement to the rightauricle of the heart).

During walking, as the foot is dorsally flexed, the contraction of thecalf muscle compresses the deep veins and soleal sinuses therebyemptying them of blood. As the foot is plantarly flexed, the pressure inthe veins falls, the proximal valves close, and the veins are refilledby blood passing through the perforators from the superficial system.During this cycle, in a normal leg, the distal valves of the deep veinsand the valves of the perforators will ensure that the expelled bloodcan go in only one direction—upwards, back to the heart.

Blockage or damage to the venous system will cause disruption to normalblood flow, which may manifest itself in a number of different waysaccording to the site and extent of the damage. If the valves in thesuperficial system are affected, venous return will be impaired andblood may accumulate in the veins causing them to become distended,leading to the formation of varicosities (varicose veins).

If the function of the perforator valves is impaired, the action of thecalf muscle pump will tend to cause blood to flow in the reversedirection into the superficial system increasing the possibility ofdamage to the superficial vessels.

Following a deep vein thrombosis that results in complete or partialobstruction of a deep vein, the unrelieved pressure produced by the calfmuscle pump on the perforator valves may cause these to becomeincompetent. In this occurs, there will be a large rise in the pressurein the superficial system, which may force proteins and red cells out ofthe capillaries and into the surrounding tissue. Here, the red cellsbreak down releasing a red pigment that causes staining of the skin, anearly indicator of possible ulcer formation.

Venous leg ulcers are generally shallow and red in color. The skinsurrounding the ulcer is frequently discolored due to the stainingdescribed previously. Incompetent perforating vein valves can also causemalleolar venules to become dilated and appear as fine red threadsaround the ankle. This condition, called ankle flair, is also diagnosticof a venous ulcer.

For patients with venous disease, the application of externalcompression can help to minimize or reverse the skin and vascularchanges described previously, by forcing fluid from the interstitialspaces back into the vascular and lymphatic compartments. As thepressure within the veins of a standing subject is largely hydrostatic,it follows that the level of external pressure that is necessary tocounteract this effect will reduce progressively up the leg, as thehydrostatic head is effectively reduced. For this reason it is usual toensure that external compression is applied in a graduated fashion, withthe highest pressure at the ankle. The preferred value for the degree ofpressure varies according to a number of factors, including the severityof the condition and the height and limb size of the patient.

Medical hosiery represents a useful and convenient method of applyingcompression to normal shaped legs in order to prevent the development orrecurrence of leg ulcers. However, these stockings are of limited valuein the treatment of active ulceration, being difficult to apply overdressings. In such situations compression bandages currently representthe treatment of choice. Compression bandages apply a pressure to thelimb that is directly proportional to bandage tension but inverselyproportional to the radius of curvature of the limb to which it isapplied. This means, therefore, that a bandage applied with constanttension to a limb of normal proportions will automatically producegraduated compression with the highest pressure at the ankle. Thispressure will gradually reduce up the leg as the circumferenceincreases.

As can be readily appreciated, it is cumbersome and difficult to applyuniform tension to the compression bandage as it is applied to thetreated limb, and thus this is accomplished only by highly skilledcaregivers. Moreover, once secured to the treated limb, care andattention must be given to ensure that the bandage does not slip orbecome displaced as this will lead to multiple layers forming, which inturn may lead to localized areas of high pressure, which can place thepatient in direct risk of skin necrosis.

Mechanical compression treatments have also been proposed. An exemplarycompression device is described in U.S. Pat. No. 5,031,604 to Dye. Asgenerally described at col. 2, lines 33 et seq., an arrangement ofchambers are provided that circumscribe the leg. An active pneumaticcontrol system controls the pressure in the chambers to squeeze the legnear the ankle and then squeeze sequentially upward toward the knee inorder to move blood from the extremity toward the heart. As noted incol. 4, lines 20-59 of U.S. Pat. No. 6,488,643 to Tumey et al., themechanically produced compression levels may produce ischaemic (i.e.,localized tissue anemia) not noted at similar compression levelsobtained through bandaging. It may also produce cuffing (i.e., areduction in leg pulsatile blood flow). The pneumatic control system isalso bulky and heavy, which severely limits the mobility of the patientduring treatment. Moreover, the pneumatic control system fails toprovide a mechanism to ensure that excessive pressure, which can causenecrosis, is not applied to the treated limb. These limitations haveresulted in most mechanical compression devices being contraindicatedfor patients exhibiting deep-vein thrombosis. Consequently, thoseskilled in the art have to date avoided such mechanical compressiondevices for the treatment of venous ulcers or edema of the extremities.

Thus, there are many problems, obstacles and challenges associated withthe current treatments of leg ulcers and there is a need in the art toprovide an apparatus for the treatment of venous ulcers (or an adema orother wound of the leg) that is simple to use, that is sure to producethe desired treatment, and that does not severely limit the mobility ofthe patient.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide an apparatus forcompression therapy that is easy to use and provides accurate andadjustable control over the pressure applied to the treated areas of ahuman limb.

It is another object of the invention to provide such an apparatus thatis slim and lightweight and thus does not severely limit the mobility ofthe patient during treatment.

It is a further object of the invention to provide an apparatus thatensures that excessive pressure, which can cause necrosis, is notapplied to the treated limb.

It is another object of the invention to provide such an apparatus thatcan be used to effectively apply pressure to the treated areas of theleg in conjunction with treatment of varicose veins in the limb over awide range of patients and symptoms.

In accord with these objects, which will be discussed in detail below,an apparatus is provided for applying compression therapy to anextremity of the human body, such as a portion of the human leg. Thedevice includes a flexible member and an air bladder chamber. Theflexible member is adapted to wrap around the extremity to secure theair bladder chamber to the extremity. An optional air pumping mechanismmay be operated to inflate the air bladder chamber to a pressurizedstate. One or more fluid-filled pressurized members are provided, eachseparate and distinct from the flexible member and the air bladderchamber and thus readily moveable relative to the flexible member andthe air bladder chamber. The pressurized member(s) is operably disposedbetween the extremity and the flexible member whereby it appliesincreased localized pressure to the extremity during use. Thepressurized member may be provided with a sponge which acts as the lowersurface of the member. The sponge may be retained by a flange whichextends partly or completely around the periphery of the pressurizedmember. The sponge may be removable and replaceable, or alternatively,it may be affixed to the pressurized member. The position of the airchamber can be readily adapted to apply local pressure to desired bodyparts (such as certain venous channel). The pressurized member(s) can bepositioned during use such that it covers a venous ulcer (or othertreatment sites) and applies increased localized pressure to thetreatment site in order to promote healing.

According to one embodiment of the invention, the air bladder chamber issubstantially longer in a first dimension than in a second dimensionorthogonal thereto such that it can extend longitudinally along theextremity to cover a relatively long and narrow portion of theextremity. When the flexible member and air bladder chamber are securelyheld over the long narrow portion of the leg and the air bladder chamberis inflated to the desired pressure, local pressure is applied to thelong narrow leg portion. Such local pressure is useful in conjunctionwith treatment of varicose veins in specific areas of the lower leg asdescribed herein.

According to a preferred embodiment of the present invention, the airpumping mechanism of the device comprises a pumping bulb and valve thatare manually manipulated to inflate the air bladder chamber.

According to yet another embodiment of the invention, the deviceincludes a pressure gauge in fluid communication with the air bladderchamber, which provides a visual indication of pressure levels withinthe air bladder chamber.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an isometric view of a pneumatic compression mechanism inaccordance with the present invention, showing the mechanism in itsunwrapped state.

FIG. 1B is an isometric view of an alternate compression mechanism inaccordance with the present invention, showing the mechanism in itsunwrapped state.

FIGS. 2A-2E are views of a fluid-filled member that is used inconjunction with the bladder-based compression mechanism of FIGS. 1A and1B to apply increased localized pressure to a venous ulcer (or to someother type of treatment site such as an adema or wound) in accordancewith the present invention; FIG. 2A is a side view of the fluid-filledmember; FIG. 2B is a top view of the fluid-filled member; FIG. 2C is aperspective view of the fluid-filled member; FIG. 2D is a front view ofthe fluid-filled member of FIG. 2A; and FIG. 2E is a partialcross-section schematic view of the fluid-filled member showing fluidtherein.

FIGS. 2F and 2G are alternative embodiments of the fluid-filled member,with FIG. 2F showing a fluid-filled member having a removable sponge ona lower surface, and FIG. 2G showing a fluid-filled member having anaffixed sponge on the lower surface.

FIG. 2H is another alternative embodiment of the fluid-filled memberhaving an arcuate shape.

FIGS. 3A and 3B are views of the pneumatic compression mechanism of FIG.1A and the fluid-filled member of FIGS. 2A-2D, showing the compressionmechanism securely wrapped around the lower leg of a human patient andenveloping the fluid-filled member; FIG. 3A shows the air bladder of thecompression mechanism disposed along the calf of the leg for applyingpressure to short saphenous vein of the lower leg; and FIG. 3B shows thefluid-filled member covering a venous ulcer disposed on the tibia of thelower leg for applying increased localized pressure to the venous ulcer.

FIG. 4A is a view of an embodiment of a pneumatic compression mechanismin accordance with the present invention; the compression mechanism isintended to be wrapped around the lower leg for application of localizedpressure to the lower leg in the vicinity of the short saphenous vein;the compression mechanism is shown in its unwrapped state with itsbody-contacting surface facing out of the page.

FIG. 4B is an isometric view of the air bladder chamber of the pneumaticcompression mechanism of FIG. 4A.

FIG. 4C is a top view of the air bladder chamber of FIG. 4B.

FIG. 4D is an exploded view showing the coupling of valve elements and aconnector to the air bladder chamber of FIGS. 4B and 4C.

FIG. 5A is a view of an embodiment of a pneumatic compression mechanismin accordance with the present invention; the compression mechanism isintended to be wrapped around the upper leg (e.g., thigh) forapplication of localized pressure to the upper leg in the vicinity ofthe long saphenous vein; the compression mechanism is shown in itsunwrapped state with its body-contacting surface facing into the page.

FIG. 5B is an isometric view of the air bladder chamber of the pneumaticcompression mechanism of FIG. 5A.

FIG. 5C is a top view of the air bladder chamber of FIG. 5B.

FIG. 5D is an exploded view showing the coupling of valve elements and aconnector to the air bladder chamber of FIGS. 5B and 5C.

FIG. 6 is a schematic illustration of a battery-powered air pumpsuitable for inflating the air bladder chamber(s) of the pneumaticcompression mechanisms described herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For purposes herein, the terms “limb” and “extremity” are usedinterchangeably and are to be understood to include the arms, hands,legs, and feet.

Turning now to FIG. 1A, a pneumatic compression mechanism is providedfor applying pressure to the lower leg of the human body. The pneumaticcompression mechanism 10 includes a flexible member 12 and one or moreinflatable air bladder chambers 14 (preferably, a single air bladder asshown). The inflatable air bladder chamber 14 is preferably secured tothe flexible member 12 in its unwrapped state. For example, the flexiblemember 12 may comprise two layers of elastomeric material with the airbladder chamber(s) 14 affixed between these two layers by nylon threadsor other suitable fastening means. Alternatively, the flexible member 12may include pockets into which the air bladder chamber(s) 14 areremovably inserted and securely held therein. In yet another alternativeembodiment, the air bladder may be glued or welded to the inside surfaceof the member 12. The elastomeric material of the member 12 may berealized from nylon, polyurethane, cotton, or other suitable material. Atube 16, which is in fluid communication with the air bladder chamber(s)14, extends to a pumping bulb 18. The pumping bulb 18, which ispreferably made of rubber, includes a valve 20 that regulates thepumping of air into the air bladder chamber(s) 14 via the tube 16. Airis pumped into the air bladder chamber(s) 14 by squeezing the pumpingbulb 18. In this manner, the air bladder chamber(s) 14 are placed into apressurized state. Preferably, a pressure gauge 22 is operably coupledto the air bladder chamber(s) 14 to provide a visual indication of thepressure level therein. An automatic pressure relief valve 23 and amanual pressure relief valve 24 may be operably coupled to the airbladder chamber(s) 14, for example via the tube 16. The automaticpressure relief valve 23 automatically vents the air in the chamber(s)14 to the ambient environment when the internal pressure reaches acertain threshold maximum pressure. In the preferred embodiment, thisthreshold maximum pressure is between 30 to 40 mmHg, and most preferablyaround 40 mmHg; however it can be varied based upon the desiredtreatment. In this manner, the pressure inside the chamber(s) 14 cannotexceed the threshold maximum pressure, thereby reducing the danger ofnecrosis and other complications that arise from excessive pressure. Themanual pressure relief valve 24 vents the air in the chamber(s) 14 tothe ambient environment when manually actuated by the patient (orcaregiver). In this manner, it facilitates quick and easy control overthe internal pressure of the air chamber(s) 14. In alternativeembodiments, the manual pressure relief valve 24 and possible theautomatic relief valve 23 may be integrated into a common package.

The air bladder chamber 14 is substantially longer in a first dimension(e.g., the Y dimension of FIG. 1A) than in a second dimension orthogonalthereto (e.g., the X dimension of FIG. 1A) such that the air bladderchamber 14 can be positioned to extend substantially longitudinallyalong the lower leg to apply local pressure along its length (the Ydimension). Such local pressure is substantially constant along thelength of the bladder chamber 14. In the illustrative embodiment shownin FIGS. 3A and 3B, the air bladder chamber 14 is disposed such that itruns along the calf of the lower leg, which enables the air bladderchamber 14 to apply local pressure to the short saphenous vein of thepatient when securely wrapped around the patient's lower leg andinflated. However, the flexible member 12 and air bladder chamber 14 maybe adapted such that they are disposed along another portion of thelower leg (e.g., a portion of the leg below the knee), which enables theair bladder chamber 14 to apply local pressure to such portion of thelower leg when inflated.

The flexible member 12 may include a strap (not shown) that extendsaround the heal (and/or other parts) of the foot when in use. This straplimits the upward travel of the flexible member 12 when in use. It mayalso have suspender hooks or slots (not shown) that allow for suspendersto be mated thereto which support the mechanism 10 by a band that wrapsaround the knee or thigh. The suspenders limit downward travel of theflexible member 12 when in use. These features reduce the travel of theflexible member 12 along the length of the leg such that its desiredposition is maintained during use.

In alternative embodiments, the flexible member 12 and air bladderchamber 14 may be adapted such that they are disposed along a portion ofthe upper leg (e.g., a portion of the thigh), which enables the airbladder chamber 14 to apply local pressure to such portion of the upperleg when inflated. For treatment of the upper leg, the flexible member12 may define an opening (not shown) at the knee joint level to enablethe patella (knee cap) to protrude therethrough. In this configuration,the flexible member 12 may extend below the knee joint level andsecurely wraps around portions of the lower leg to provide stability tothe leg. It may also have suspender hooks or slots (not shown) thatallow for suspenders to be mated thereto in order to support themechanism 10 by a waist band when in use. The suspenders limit downwardtravel of the flexible member 12 when in use such that the flexiblemember 12 maintains its desired position.

Preferably, the flexible member 12 includes multiple hook and loopclosure mechanisms 26A, 26B (e.g., VELCRO® members). In the preferredembodiment, the flexible member includes four hook and loop closuremechanisms as shown in FIGS. 1A and 3A. These multiple closures enablethe flexible member 12 and the air bladder chamber(s) 14 to be securelywrapped around a portion of the human leg. If desired, other suitablefastening means may be used to secure the flexible member and the airbladder chamber(s) to the human leg. For example, the flexible membermay be adapted to form a sleeve-like shape with a zipper running alongits length dimension. Alternatively, the zipper may be omitted such thatsleeve-like flexible member is slid over the patient's leg until it isdisposed in the desired position.

Preferably, pressure in the air bladder chamber(s) is reduced/removed(e.g., the air bladder chamber(s) are deflated) by user manipulation ofthe manual relief valve 24, and the pneumatic compression mechanism isremoved from the leg by manually detaching the hook and loop closuresand unwrapping the flexible member 12 from around the leg.

FIG. 1B illustrates an alternative compression mechanism 110 whichincludes a flexible member 112 and one or more pre-inflated (pre-filled)air bladder chambers 114 (preferably, a single air bladder as shown).The pre-inflated air bladder chamber 114 is preferably secured to theflexible member 112 in its unwrapped state. For example, the flexiblemember 112 may comprise two layers of elastomeric material with the airbladder chamber(s) 114 affixed between these two layers by nylon threadsor other suitable fastening means. Alternatively, the flexible member112 may include pockets into which the air bladder chamber(s) 114 areremovably inserted and securely held therein. In yet another alternativeembodiment, the air bladder may be glued or welded to the inside surfaceof the member 112. Regardless, a pressure gauge 122 is operably coupledto the air bladder chamber(s) 114 to provide a visual indication of thepressure level therein. The flexible member 112 also includes multiplestraps 125 having hook and loop closure mechanisms 126A, 126B (e.g.,VELCRO® members), and multiple openings 127 for receiving the straps. Inthe preferred embodiment, the flexible member includes three straps 125and three openings 127. In use, the straps are threaded through theopenings and back on themselves such that the hook and loop closuremechanisms 126A and 126B engage each other. By pulling the straps tightand affixing them using the closure mechanisms, more or less pressuremay be applied to the pre-filled bladder; thereby applying more or lesspressure to the limb on which the compression mechanism is applied. Theamount of pressure applied may be read by the pressure gauge 122 whichmay have numerical or other visible indications.

FIGS. 2A-2E illustrate a fluid-filled member 30 that is used inconjunction with the compression mechanisms 10, 110 of FIGS. 1A and 1Bto apply increased localized pressure to a venous ulcer (or to someother type of treatment site such as an adema or wound). Thefluid-filled member 30 includes two walls 32A, 32B (FIG. 2E) that arebonded together, preferably by heat sealing, about a flange portion 34.The two walls 32A, 32B define a chamber 36 therebetween that is filledwith fluid. The top wall 32A extends orthogonally from the flangeportion 34 to form a small sidewall section 37 and then curves to form atop section 38. The top section 38 is operably disposed adjacent theflexible member 12 of the compression member 10, while the bottom wall32B is operably disposed adjacent the treatment site as described below.

The fluid held in the chamber 36 can be a gas (such as air), a liquid(such as water), or a gel. The underside surface 38 of the flangeportion 34 preferably includes a peel-off adhesive film 39 that aids insecuring the member 30 to the skin (or possibly to the flexible member12 and/or to the air bladder 14) at the treatment site. The fluid insidethe chamber 36 may be loaded with one or more therapeutic agents, suchas antibiotics, growth factor, absorbents. In such configurations, thebottom wall 32B is realized from a semi-permeable material that allowsthe therapeutic agents retained in the chamber 36 to migrate through tothe treatment site while maintaining the desired internal pressure inchamber 36. Such fluid might also be a gel compound that retains heatand/or cold such that is useful for hot and/or cold therapy of thetreatment site.

The fluid-filled member 30 preferably has an oval shape with a length onthe order of 4 inches (with a 0.25 inch wide flange), a width on theorder of 2 inches, and a height on the order of 0.75 inches as shown inFIGS. 2A-2D. It will be appreciated that the fluid-filled member 30 maytake other shapes and sizes.

A first alternative embodiment 130 of the fluid-filled member is seen inFIG. 2F. Fluid-filled member 130 includes three walls 132A, 132B, 132Cthat are bonded together, preferably by heat sealing, about a flangeportion 134. Walls 132A, 132B define a chamber 136 therebetween that isfilled with fluid. The fluid held in the chamber 136 can be a gas (suchas air), a liquid (such as water), or a gel. The top wall 132A extendsorthogonally from the flange portion 134 to form a small sidewallsection 137 and then curves to form a top section 138. The top section138 is intended to be operably disposed adjacent the flexible member 12(112) of the compression member 10 (110) (see FIGS. 1A and 1B).

Walls 132B and 132C of member 130 define a holding flap for a sponge 135by having wall 132C extend away from wall 132B. Wall 132C may extendcircumferentially completely around the member 130, or only partially atone or more locations. The underside surface of wall 132C may include apeel-off adhesive film 139 that aids in securing the member 130 to theskin. Alternatively, the top surface of wall 132A may include a peel-offadhesive film that aids in securing member 130 to the flexible member 12and/or to the air bladder 14. Sponge 135 is preferably removable andreplaceable. Thus, replacement sponges can be used for hygienicpurposes. Alternatively, sponge 135 may be affixed (e.g., via adhesive)to the underside of wall 132B.

A second alternative embodiment 230 of the fluid-filled member is seenin FIG. 2G. Fluid-filled member 230 two walls 232A, 232B (and optionallya third wall 232C) that are bonded together about a flange portion 234with walls 232A, 232B defining a chamber 236 therebetween that is filledwith fluid. Affixed to the underside of wall 232B is a sponge 235. Ifdesired, wall 232C may be used to bound the sponge 235, and a peel-offadhesive film may provided on the underside surface of wall 232C and/orto the top surface of wall 232A to aid in securing the member 230 to theskin and/or to the flexible member 12 (112) and/or to the air bladder 14(114) at the treatment site. As another alternative, wall 232C may notbe provided, and an adhesive, if desired, may be provided on theunderside surface of wall 232B.

A third alternative embodiment 330 of the fluid-filled member is seen inFIG. 2H. The fluid-filled member 330 may be constructed in the samemanner as any of the members 30, 130, 230 shown in FIGS. 2A-2E, 2F, and2G (with flange 334, chamber 336, etc., and may or may not include asponge), except that fluid-filled member 330 is crescent-shaped. Assuch, fluid-filled member 330 is particularly useful in applyingpressure to locations about the ankle. It will be appreciated that otherfluid-filled members of other shapes could be utilized to apply pressureto the heal, and other parts of the body.

The compression mechanism of FIG. 1A or FIG. 1B and the fluid-filledmember of FIGS. 2A-2H are used to apply pressure to the lower leg duringtreatment. For example, FIG. 3A shows the air bladder 14 of thecompression mechanism 10 of FIG. 1A disposed along the calf 51 of theleg 53 for applying pressure to short saphenous vein (shown as dottedline pair 54) of the lower leg 55. FIG. 3B shows one fluid-filled member30 (130, 230), which is disposed in the cutaway portion under theflexible member 12, covering a venous ulcer (not shown) disposed on thetibia of the lower leg 55. In this configuration, the fluid-filledmember is placed over the treatment site (i.e., the venous ulcer). It isenveloped by wrapping the flexible member 12 around the lower leg 55with the air bladder chamber(s) 14 disposed along the calf 50 of the legas shown in FIG. 3A. Pressure is applied to the air bladder chamber(s)14 by manipulating the pumping bulb 18 until the air bladder chamber(s)is (are) inflated to a desired target pressure, preferably on the orderof 40-80 mmHg. Preferably, this target pressure level is visuallyindicated on the pressure gauge 22. The local pressure applied by theinflated air bladder chamber 14 is substantially constant along thelength of the bladder chamber 14. The fluid-filled member appliesincreased and more localized pressure to its treatment site, which isexpected to aid in the healing of the treatment site. It any time (e.g.,daily), the pressure may be released, and the flexible member removed orloosened from the leg, so that the fluid-filled member can be removed.Then, where a replaceable sponge is being utilized on the undersurfaceof the fluid-filled member (e.g., member 130 of FIG. 2F), the sponge maybe replaced, the fluid-filled member relocated over the treatment site,the flexible member 12 rewrapped around the lower leg 55, and pressurereapplied to the air bladder chamber(s) 14 disposed along the calf 50 ofthe leg. This may be done as often as necessary or until healing.Similarly, where the fluid-filled member does not include a replaceablesponge, a new sponged fluid-filled member (e.g., member 230 of FIG. 2G)may be used as necessary.

The compression mechanism of FIG. 1A or FIG. 1B and one or morefluid-filled members of FIGS. 2A-2G can be used in conjunction with veinligation and/or surgical vein stripping, whereby pressure is applied tothe treated venous channels by the air bladder of the compressionmechanism. In this application, the air bladder chamber applies localpressure to the treatment area to control bleeding that results fromthis procedure. Such local pressure is substantially constant along thelength of the bladder chamber. The fluid-filled member(s) appliesincreased and more localized pressure over a venous ulcer (or othertreatment site). Similarly, when used in conjunction with sclerotherapy,the air bladder chamber applies local pressure to the treatment area tosignificantly reduce the amount of blood that pools (or mightpotentially flow back) into the treated venous channel. This enables thesclerosing agent to have maximum effect in destroying the venous channelin the treated area of the thigh. The fluid-filled member(s) may bepositioned to cover one or more localized treatment sites (for example,over spider veins that are treated with scelrotherapy) to provideincreased localized pressure to the treatment site(s) that promoteshealing.

It is also contemplated that the patient may utilize the compressionmechanism of FIG. 1A or FIG. 1B and the fluid-filled members of FIGS.2A-2G can be used in conjunction with saphenous vein harvesting. Thelong saphenous vein is typically used to bypass arterial blockages, toperform arterial bypass grafts and other cardiac procedures. Heparin istypically administered to the patient for anticoagulation purposes.However, the heparin also prevents clot formation in and around the areaof the harvested vein, which may cause generalized bleeding or oozing toform a hematoma and possibly an infection or other complication. In thisapplication, localized pressure is applied to the harvested venouschannel by the air bladder of the compression mechanism. Such localpressure is substantially constant along the length of the bladderchamber. The fluid-filled member applies increased and more localizedpressure over the hematoma (or other treatment site such as in incisionsite) to promote healing.

Furthermore, it is contemplated that the patient may utilize thecompression mechanism of FIG. 1A or FIG. 1B and one or more of thefluid-filled members of FIGS. 2A-2H to apply increased and morelocalized pressure to the treated areas of the leg for an extendedperiod of time (e.g., periods of days/weeks) subsequent to treatment.

It should be noted that amount of fluid that is added to the chamber 36at the time it is filled and/or the volume of chamber 36 is fixed bydesign. These parameters dictate the internal pressure of the chamber36. In other words, the internal pressure of the chamber 36 is static.However, by adjusting the amount of fluid added to the chamber 36 atfill time or by adjusting the volume of chamber 36 or by adjusting bothparameters, the internal pressure of the chamber 36 can vary. Moreparticularly, the internal pressure of chamber 36 is proportional to theamount of fluid added to the chamber 36 at fill time and inverselyproportional to the volume of chamber 36. These relationships can beexploited to provide a set of fluid-filled members (30A, 30B, 30C . . .) that have varying internal pressures. For, example, the fluid-filledmembers of the set can have the same volume but are filled withdifferent amounts of fluid to provide the varying internal pressures.Alternatively, the fluid-filled members of the set can have differentvolumes that are filled with the same amount of fluid to provide thevarying internal pressures. Preferably, the set of fluid-filled membersand one or more compression apparatus are packaged as a kit. Theparticular fluid-filled member that is expected to provide the desiredincrease in local pressure is selected from the set and used inconjunction with the compression apparatus as described above. Trial anderror may be used to identify the appropriate fluid filled member forthe desired treatment.

Turning now to FIGS. 4A-4D, an alternate embodiment of a pneumaticcompression mechanism is shown. The pneumatic compression mechanism 10′includes a flexible member 12′ and one or more inflatable air bladderchambers 14′ (preferably, a single air bladder as shown). The inflatableair bladder chamber 14′ may be formed from two walls that are bondedtogether, preferably by heat sealing, about a flange portion in a mannersimilar to the fluid-filled members 30 as described herein. The airbladder chamber 14′ is secured to the inside surface of the flexiblemember 12′ preferably by gluing, welding or other suitable fasteningmeans. Alternatively, the flexible member 12′ may comprise two layers ofelastomeric material with the air bladder chamber(s) 14′ affixed betweenthese two layers by nylon threads or other suitable fastening means. Theflexible member 12′ is preferably realized from nylon, polyurethane,cotton, or other suitable material. A connector 16A′ is in fluidcommunication with the air bladder chamber(s) 14′ via a port 17A′, whichpreferably extends through the bottom side of the air bladder chamber14′ as shown in FIG. 4D. The connector 16A′ mates to an inflation tube(not shown) for fluid connection to the pumping bulb as described aboveor other inflation mechanisms (such as a battery-powered pump as shownin FIG. 6). An automatic pressure relief valve 23′ and a manual pressurerelief valve are in fluid communication with the air bladder chamber(s)14′ via ports 17B′ and 17C′, respectively, which preferably extendthrough the bottom side of the air bladder chamber(s) 14′ as shown inFIG. 4D.

Preferably, the flexible member 12′ includes multiple hook and loopclosure mechanisms (e.g., VELCRO® members) which enable the flexiblemember 12′ (and the air bladder chamber(s) 14′ secured thereto) to besecurely wrapped around a portion of the human leg. In the exemplaryembodiment of FIGS. 4A-4D, the flexible member 12′ includes three hookbuttons 26A1′, 26A2′, 26A3′ disposed on the body-contacting side ofmember 12′ that mate to a larger loop panel section 28B′ disposed on theopposite side of member 12′. If desired, other suitable fastening meansmay be used to secure the flexible member 12′ and the air bladderchamber(s) 14′ to the human leg. For example, the flexible member 12′may be adapted to form a sleeve-like shape with a zipper running alongits length dimension. Alternatively, the zipper may be omitted such thatsleeve-like flexible member 12‘is slid over the patient’s leg until itis disposed in the desired position. The flexible member 12′ may alsoinclude cut-outs (not shown) which provide enhanced flexibility of themember 12′.

During use, air is pumped into the air bladder chamber(s) 14′ byactuation of the pumping bulb (or other inflation mechanism). The airbladder chamber 14′ is substantially longer in a first dimension (e.g.,the Y dimension of FIGS. 4A and 4C) than in a second dimensionorthogonal thereto (e.g., the X dimension of FIGS. 4A and 4X) such thatthe air bladder chamber 14′ can be positioned to extend substantiallylongitudinally along the leg to apply local pressure along its length(the Y dimension). Such local pressure is substantially constant alongthe length of the bladder chamber 14′.

In the exemplary embodiment shown, the air bladder chamber 14′ has alength of 13.00 inches (Y dimension) and width of 3.77 inches and 3.51inches (X dimension) at its top and bottom ends, respectively, as shown.The width of the chamber 14′ tapers as it extends away from the top andbottom ends to a minimal width, which is located relatively closer tothe bottom end as shown. It will be appreciated that the air bladderchamber 14′ may take other shapes and sizes.

One or more fluid-filled members 30 (130, 230) can be is used inconjunction with the pneumatic compression mechanism 10′ of FIGS. 4A-4Dto apply increased localized pressure to a treatment site in a mannersimilar to those described above.

In an exemplary application, the air bladder chamber 14′ is positionedsuch that that it runs along the calf of the lower leg and covers theshort saphenous vein of the patient as shown in FIGS. 3A and 3B. It issecured in this position by wrapping the flexible member 12′ around thelower leg and closing it with closure mechanisms 26A 1′, 26A2′, 26A3′and 26B′. The air bladder chamber 14′ is inflated to its desiredpressure to apply local pressure to short saphenous vein of the patient.One or more fluid-filled members 30 (130, 230) can be positioned abovetreatment site(s) (e.g., a venous ulcer) before securing the flexiblemember 12′ to the lower leg to apply increased and more localizedpressure on the treatment site(s) to promote healing. After inflatingthe chamber 14′ to its desired pressure, the inflation pump can bedecoupled from the connector 16A′ and replaced with a plug (not shown).The flexible member 12′ includes a strap 29′ that extends around theheal (and/or other parts) of the foot during use. A hook closure segment29A′ mates to loop panel section 26B′ to secure the strap 29′ around thefoot. The strap 29′ limits the upward travel of the flexible member 12′during use. The member 12′ may also have one or more slots 61′ (forexample five shown) that allow for suspenders (not shown) to be matedthereto which support the mechanism 10′ by a band that wraps around theknee or thigh. The suspenders limit downward travel of the member 12′when in use. Thus, the strap and the suspenders cooperate to reduce thetravel of the flexible member 12′ along the length of the leg such thatits desired position is maintained during use.

As another alternative, instead of using an inflatable air bladderchamber 14′ as shown in FIGS. 4A-4D, the air bladder chamber shown inFIGS. 4A-4D may be pre-filled as described above with reference to FIG.1B. The so-modified air bladder chamber may then be used as describedabove with or without one or more of the fluid-filled member 30, 130,230.

In alternative embodiments as shown in FIGS. 5A-5D, a flexible member12″ and air bladder chamber 14″ are adapted such that they are disposedalong a portion of the upper leg (e.g., a portion of the thigh), whichenables the air bladder chamber 14″ to apply local pressure to suchportion of the upper leg when inflated. The structure and operation ofthe elements of the mechanism 10″ are analogous to the mechanism 10′ asdescribed above with respect to FIGS. 4A-4D, and thus description ofsuch elements (which are labeled with like numbers) are omitted forsimplicity of description.

In the exemplary embodiment shown, the flexible member 12″ is contouredto conform to the upper leg when wrapped around it. The air bladderchamber 14″ has a length of 11.75 inches (Y dimension) and maximum widthof 6.00 inches (X dimension) at its bottom end as shown. The width ofthe chamber 14″ tapers as it extends away from the bottom end to the topend as shown. It will be appreciated that the air bladder chamber 14″may take other shapes and sizes.

One or more fluid-filled members 30 (130, 230) can be is used inconjunction with the pneumatic compression mechanism 10″ of FIGS. 5A-5Dto apply increased localized pressure to a treatment site in a mannersimilar to those described above.

In an exemplary application, the chamber 14″ is positioned such thatthat it runs along the thigh and covers the long saphenous vein of thepatient. It is secured in this position by wrapping the flexible member12″ around the thigh and closing it with closure mechanisms 26A1″,26A2″, 26A3″ and 26B″. The air bladder chamber 14″ is inflated to itsdesired pressure to apply local pressure to long saphenous vein of thepatient. One or more fluid-filled members 30 (130, 230) can bepositioned above treatment site(s) (e.g., a venous ulcer) beforesecuring the flexible member 12″ to the upper leg in order to applyincreased and more localized pressure on the treatment site(s) topromote healing. After inflating the chamber 14″ to its desiredpressure, the inflation pump can be decoupled from the connector 16A″and replaced with a plug (not shown). The flexible member 12″ hassuspender hooks or slots 61″ as shown in FIG. 5A. The hooks or slots 61″allow for suspenders 63″ to be mated thereto in order to support themechanism 10″ by a waist band when in use. The suspenders 63″ limitdownward travel of the flexible member 12″ when in use such that theflexible member 12″ maintains its desired position. The flexible member12″ may also define an opening (not shown) at the knee joint level toenable the patella (knee cap) to protrude therethrough. In thisconfiguration, the flexible member 12′ may extend below the knee jointlevel and securely wraps around portions of the lower leg to providestability to the leg.

As another alternative, instead of using an inflatable air bladderchamber 14′ as shown in FIGS. 5A-5C, the air bladder chamber shown inFIGS. 5A-5C may be pre-filled as described above with reference to FIG.1B. The so-modified air bladder chamber may then be used as describedabove with or without one or more of the fluid-filled member 30, 130,230.

FIG. 6 illustrates a battery-powered air pump 601 suitable for inflatingthe air bladder chamber(s) of the pneumatic compression mechanismsdescribed herein. The pump 601 includes a housing 603 that houses one ormore batteries (two shown as 605 a, 605 b) that power a pneumatic airpump 607. An on/off switch 609, which is electrically coupled betweenthe batteries and the air pump 607, that manually manipulated to controlthe supply of battery power to the air pump. When the switch 609 is ON,battery power is applied to the air pump such that it pumps air througha nozzle 611. The nozzle 611 is fluidly coupled to the air bladderchamber(s) of the pneumatic compression mechanisms described herein forinflation of such chamber(s).

Advantageously, the compression mechanisms and fluid-filled members ofthe present invention provide for accurate control and monitoring oflocalized pressure applied to the treated areas of a human leg.Moreover, they are simple to use, lightweight and flexible and thus donot significantly reduce the mobility of the patient. Finally, becausethe fluid-filled members are separate and distinct from the compressionwrap, they can be positioned between the extremity and the wrap memberat arbitrary locations. This flexibility allows for increased localizedpressure to be applied over a wide range of locations on the extremityand thus allows the treatment to be more effectively tailored to theinjuries/symptoms of the patient.

In alternate embodiments with respect to those described above, themember and the inflatable air bladder chamber may be adapted such thatthey are separate and distinct from one another and thus moveablerelative to one another when the member is in its unwrapped state. Thisfeature allows for flexibility in positioning of the air bladderchamber. This flexibility allows for the pressure therapy to be appliedover a wide range of locations on the extremity and thus allows thetreatment to be more effectively tailored to the injuries/symptoms ofthe patient.

In accord with another aspect of the invention, one or more of thefluid-filled members of FIGS. 2A-2H with or without adhesive backing,and with or without a sponge member may be used in conjunction with andunder a pressure applying means (such as the compression devices of FIG.1A or FIG. 1B, or an ACE bandage) to act as a bolster in order to applylocalized pressure to a wound. If desired, a foam, sponge, or otherdressing may be applied under the fluid-filled member. Thus, in accordwith a method of the invention, a dressing, foam, sponge, or othermember of desired size and shape is applied to a wound, afluid-pre-filled member is placed over the dressing, foam, sponge orother member to act as a bolster, and then a pressure-applying wrap isapplied over the fluid-pre-filled member.

There have been described and illustrated herein preferred embodimentsof an apparatus (and corresponding methods of operation) that is securedto a portion of the human limb and controlled to apply localizedpressure to portions of the human limb. While particular embodiments ofthe invention have been described, it is not intended that the inventionbe limited thereto, as it is intended that the invention be as broad inscope as the art will allow and that the specification be read likewise.Thus, while particular fastening mechanisms and particular pressurecontrol mechanisms have been disclosed, it will be appreciated thatother suitable mechanisms that may be used as well. For example, the airpump mechanism may include an automatic air pumping mechanism (such asthe battery-powered air pump of FIG. 6) rather than a hand-held manuallyactuated air pumping mechanism as described above. In addition, the airpump mechanism may be removably coupled to tubing that leads to thepressure valve and air chamber(s) of the device such that air pumpmechanism can be disconnected from the device with the pressure valveclosed (thereby maintaining the device in its pressurized state). Also,the pneumatic compression mechanism may extend to cover lower and/orhigher portions of the leg than those shown. In yet alternativeembodiments, the compression mechanisms can be used to apply localizedpressure to other veins of the leg or to other extremities, such as thearm, for wound healing or other treatments. It will therefore beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as claimed.

1. A system for applying pressure to a limb of the human body,comprising: a) a flexible member and an air bladder chamber, whereinsaid flexible member is adapted to wrap around the limb to secure saidair bladder chamber to the limb; and b) at least one pressurized member,separate and distinct from said flexible member and said air bladderchamber and thus moveable relative to said flexible member and airbladder chamber, which is operably disposed between the limb and theflexible member whereby it applies increased localized pressure to thelimb, said at least one pressurized member having a sponge on at leastone surface.
 2. A system according to claim 1, further comprising: c) anair pumping mechanism, operably coupled to said air bladder chamber,that operates to inflate said air bladder chamber to a pressurizedstate.
 3. A system according to claim 1, wherein: said air bladderchamber is substantially longer in a first dimension than in a seconddimension orthogonal thereto such that the air bladder chamber isoperably positioned to extend longitudinally along the limb to cover aportion of the limb that is relatively long and narrow.
 4. A systemaccording to claim 1, wherein: said pressurized member has peripheralportion having securing means for securing said pressurized member tothe limb.
 5. A system according to claim 4, wherein: said securing meanscomprises a peel-off adhesive strip suitable for adhering to the skin.6. A system according to claim 1, wherein: said pressurized membercomprises two walls that are joined together at their periphery to forma peripheral flange and also define a chamber therebetween that isfilled with a fluid to a pressurized state.
 7. A system according toclaim 6, wherein: said pressurized member comprises three walls that arejoined together at their periphery to form a peripheral flange, a firstand a second of said three walls also defining a chamber therebetweenthat is filled with a fluid to a pressurized state, and said second anda third of said three wall forming a flap which retains said sponge. 8.A system according to claim 7, wherein: said sponge is removablyretained in said flap.
 9. A system according to claim 7, wherein: saidflap extends completely around said pressurized member.
 10. A systemaccording to claim 7, wherein: said flap extends partially around saidpressurized member.
 11. A method of applying compression therapy to alimb, comprising: a) providing a device for applying pressure to thelimb; b) providing at least one pressurized member, separate anddistinct from said device and thus moveable relative to said device,said at least one pressurized member having a sponge; c) positioningsaid pressurized member such that said sponge at least partially coversa treatment site; and d) manipulating said device such that device issecurely wrapped around and applies pressure to the limb, whereby thepressurized member is operably disposed between the limb and said deviceand applies increased localized pressure to the limb.
 12. A methodaccording to claim 11, wherein: said device includes a flexible memberand an air bladder chamber, wherein said flexible member is adapted towrap around the limb to secure said air bladder chamber to the limb. 13.A method according to claim 12, wherein: said air bladder chamber is aninflatable air bladder chamber, and said manipulating comprisesinflating said air bladder chamber to a pressurized state.
 14. A methodaccording to claim 12, wherein: said device includes an air pumpingmechanism operably coupled to said air bladder chamber, that operates toinflate said air bladder chamber to a pressurized state.
 15. A methodaccording to claim 14, wherein: said air pumping mechanism comprises apumping bulb, and said inflating comprises manually manipulating saidpumping bulb to inflate said air bladder chamber to said pressurizedstate.
 16. A method according to claim 11, wherein: said at least onepressurized member comprises securing means having a peel-off adhesivestrip, and said positioning comprises peeling off the adhesive strip andaffixing the pressurized member on the limb such that it covers thedesired treatment site.
 17. A method according to claim 12, wherein:said device includes a plurality of hook and loop closures affixed tosaid flexible member that are joined together to securely wrap saidflexible member around the limb, and said manipulating comprisesmanually joining said plurality of hook and loop enclosures to securelywrap said flexible member around the limb.
 18. A method according toclaim 11, further comprising: replacing said sponge on said pressurizedmember.
 19. A method according to claim 11, further comprising:replacing said pressurized member having a sponge with a secondpressurized member having a sponge.
 20. A pressurized apparatus,comprising: at least two walls that are joined together at theirperiphery to form a peripheral flange, a first and a second of said atleast two walls defining a chamber therebetween that is filled with afluid to a pressurized state; and a sponge located opposite said chamberfrom said second wall and retained against said second wall.
 21. Apressurized apparatus according to claim 20, wherein: said at least twowalls comprises three walls jointed together at their periphery to forma peripheral flange, said second and a third of said three walls forminga flap, said sponge removably retained in said flap.
 22. A pressurizedapparatus according to claim 21, wherein: said flap extends completelyaround said pressurized apparatus.
 23. A pressurized apparatus accordingto claim 20, wherein: said sponge is affixed to said second wall.
 24. Amethod for treating a wound on a limb, comprising: applying a dressing,foam, sponge, or other member of desired size and shape to the wound;placing a pre-filled pressurized member over the dressing, foam, spongeor other member to act as a bolster; and applying a pressure-applyingwrap over the fluid-pre-filled member and on the limb, whereby thepre-filled pressurized member is operably disposed between the dressing,foam, sponge or other member and said pressure-applying wrap, andapplies increased localized pressure to the wound.